Collection of COVID-19 Convalescent Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Number of patients who consent to plasma donation
研究概览
简要总结
Patients who are severely ill with COVID-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. Efforts to initiate the collection and infusion of these products to high risk patients have been initiated around the world and the FDA has recently provided information about how this could be accomplished. As the Jefferson Blood Donor Center already has processes to collect, test and process blood, investigators are planning to make efforts to collect plasma for this use should it be necessary. The purpose of this study is to describe the process for identifying and collecting convalescent plasma from donors previously infected with the virus. The research portion on top of this standard blood product collection will the process of identification of subjects and processes by which blood products are processed in this special population. This protocol does not involve the administration of blood products to patients with COVID-19 infection.
详细描述
As described by the FDA on 3/24/2020, convalescent plasma has been used for a variety of infectious diseases including Ebola, SARS, MERS and H1N1 flu. Given that there is no current medical treatment beyond supportive care for COVID-19, there is a great deal of interest in using convalescent plasma for patients with COVID-19. As a first step in this process, investigators are proposing to identify donors and collect plasma with antibodies against COVID-19. While the intention is to use this for patients in the near future, the purpose of this study will be to see if this is feasible and a separate application will be submitted related to the treatment of patients with these products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Prior diagnosis of COVID-19 documented by a laboratory test approved by the FDA
- •Either: Complete resolution of all COVID-related symptoms for 14-28 days at the time of blood donation AND negative repeated SARS-CoV-2 test OR Complete resolution of all COVID-related symptoms for > 28 days
- •Male donors, never-pregnant female donors, or previously pregnant female donors negative for HLA antibodies
- •Meet all criteria for volunteer blood donation per Jefferson Blood Donor Center and the FDA
排除标准
- •Failure to pass standard volunteer blood donor screening criteria required by the Jefferson Blood Donor Center and the FDA
- •Female donors with HLA antibodies (per FDA requirements for convalescent plasma donors)
- •Inadequate venous access for phlebotomy
- •Currently pregnant
结局指标
主要结局
Number of patients who consent to plasma donation
时间窗: 1 year
# of patients who consent to donation
Number of patients who screen eligible for donation
时间窗: 1 year
# of individuals screened eligible
Number of plasma donations received
时间窗: 1 year
# of plasma donations received
次要结局
- Safety of donation procedures(1 year)